The Disaggregation Road

When we saw a conference selling itself with the concept that Big Pharma is likely to disaggregate, we began to realize that what we had once seen as a kind of quirky idea has now gained the respectability of promotional material.

So first, let us invite you to follow our logic for disaggregation: just click here (the presentation’s free).

Since that talk, at the Pharmaceutical Strategic Alliances conference in September, we’ve only become more convinced that Big Pharma – at least to thrive, if not survive -- has got to start thinking small.

Some are. The less-than-confirmed but more-than-rumored information we've got is that AstraZeneca is set to spin off its GI R&D organization, keeping of course its big commercial assets, the Nexium franchise, but letting private equity fund the early-stage candidates. Good idea, we say. AZ is simply too big to manage the internal research it’s got – let alone depend on the notion that it can afford big bets on areas unlikely to generate big advances in medical care. (For an in-depth discussion of GI R&D strategies, see this story in the November IN VIVO).

AZ has by no means abandoned primary care blockbusters, but is clearly moving towards an increasingly disaggregated future. That, it seems to us, is one key message of its independently managed MedImmune acquisition-now-division. We’ll see how much farther AZ is willing to push its strategic envelope – perhaps, eventually, all the way down the disaggregation road paved by the most successful drug company in the industry—the Roche-Genentech-Chugai cluster?

We acknowledge there’s risk to the AZ strategy (spending 20% of one’s market cap for a company providing an additional 5% of sales looks pretty dicey – even if it does provide 25% of AZ’s pipeline going forward). Disaggregation is no panacea. But big-bet development--witness Novartis' well-publicized struggles with its diabetes would-be blockbuster Galvus and the management reshuffle in the wake of that debacle--is no strategy, either.

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Big Pharma R&D Becomes Business Development …or at Least BD Now Runs Research

Lot of changes in business development recently.

In a management tiff, long-time Big Pharma dealmaker Tamar Howson rather unceremoniously left Bristol-Myers Squibb, where she’d been running worldwide business development, ending up at Bristol partner Lexicon Pharmaceuticals. Bayer-Schering, aiming again for top tier status, replaced veteran biz dev boss Chris Seaton with Michael Yeomans, ex-Aventis, via Biovail. A few weeks ago, Victor Hartmann, who in early 2005 had bailed on the top BD job at Novartis to take a flyer running BD at Vertex, left the biotech as unceremoniously as Howson left BMS; the IN VIVO Blog has got only hearsay reports on why, so we’ll leave well enough alone.

Look Out Below!

As far as our limited insight can tell us, none of these changes indicate much beyond the fact that grease coats the rungs of corporate ladders. But now news from Johnson & Johnson does reflect something we’ve long argued but which companies have been very slow to internalize structurally: Big Pharma R&D has become business development.

That’s why we’re so interested in the fact that J&J’s drug business has made its chief licensing honcho Tom Heyman head of discovery for the biggest R&D operation in its newly reorganized three-headed drug business. Heyman will be running discovery and early development for J&J's CNS/Internal Medicine Franchise, which incorporates its La Jolla, Pennsylvania/New Jersey and Belgian research sites.

Now, except for one fact, such a move wouldn’t be unprecedented. GlaxoSmithKline certainly gave its R&D organization a business development message when in 2006 it appointed its BD head, Moncef Slaoui, to run the R&D organization. But Slaoui at least had a research background; he's got a PhD. Heyman isn't a scientist at all: he’s a former patent attorney for Janssen.

Apparently this is just fine with Heyman’s new boss, Paul Stoffels, who most definitely is a scientist and one who understands the value of a business development--and an outsider's--perspective. Stoffels is the former Janssen researcher who turned some stagnating work at his former company, plus some new innovation, into a biotech called Virco. Virco in 2001 merged with fellow Belgian biotech Tibotec, and J&J purchased the combined company a year later, once Stoffels & Co. had proven its value, for some $320 million. Stoffels – following a J&J tradition – joined J&J, which hopes he can do what his predecessors clearly couldn’t.

And apparently one thing he wants to do is to make sure J&J’s discovery has a definite external spin. Heyman's certainly got the background to apply the spin; whether the organization accepts it -- from a non-scientist -- is another question.

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R&D: Worth It Only When You Don’t Pay for It

The late Michael Sorrel, one of biotech’s most perspicacious analysts, had a few basic rules for investing, one of which was the call option. Did the biotech have not merely a lead program, which could anchor the company’s valuation, but something else the stock buyer could get for free.

Same holds true with pharma. Analysts are now so skeptical of early-stage Big Pharma R&D that they want it for free. Or at least that’s the implication of some intriguing calculations from Craig Maxwell, European equity research analyst at JP Morgan.

Maxwell summed the estimated value of the six major European pharmas based solely on their current products plus their Phase III pipelines – the “embedded value” -- and then compared it to their current share prices (see chart). The closer these values came to the share value, the less the market—theorizes Maxwell—is valuing research. And that means the less the investor is paying for R&D.

Conversely, the bigger the gap between product value and share value, the greater the value the market is putting on research. No free R&D option—and a poor deal for investors.

Best value on the European market: Novo Nordisk (products equal 104% of share price). Worst deal: GSK (products equal just 74%).

Now, you can disagree with Maxwell’s estimates of product value. Maybe he’s discounting the value of GSK’s products and inflating Novo’s. But the fact that he won’t pay for R&D—that he wants it for free, and apparently can get it—seems about as damning an indictment of the value of R&D as we’ve heard in a long time.

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Can P&G Stomach the Risk Even When It's Reduced?

P&G Pharmaceuticals has been the Henny Youngman Rodney Dangerfield! of the drug industry: it couldn't get no respect. And so last year it remade itself, becoming what it calls a “search and development organization,” apparently on the model of Shire and Endo.

When it announced it was abandoning discovery, in February 2006, P&G was both admitting it couldn’t compete in research—and that it couldn’t stomach the risk. It laid off, or transferred, most of its researchers; it has spun off at least three research programs (more on that in another post); and now it’s got 45 people scouring the earth for licensable products in its chosen therapeutic areas: gastro-intestinal, musculo-skeletal and women’s health. Two key criteria: P&G only want drugs for patients that have “high involvement in their disease”; and they want products for which the development risk is “reduced.”

They’ve got some ambitious goals. To reach their growth targets, they want to launch one new product every 4-5 years – and that drug needs to become – echoing Jack Welch’s famous maxim for GE—number one or two in its category. To get to their launch target, P&G figures it will need to do 2-3 deals per year.

The question, however, is whether the kind of products that get to be #1 in their categories are also the kind of products that P&G management will be willing to pay for. It’s a challenge, admits Jeff Davis, who runs new business development. P&G has a shareholder base which demands 4-6% growth a year—that’s the kind of growth that justifies not reduced-risk research, but no-risk research, the sort that figures out how to get more or less pulp into orange juice or no-drip caps onto detergent bottles.

Moreover, while Big Pharma isn’t generally ponying up for reduced-risk development projects (in general, they still want NMEs), spec pharma is, and paying Big Pharma-sized upfronts. But P&G figures it can win these deals by emphasizing its consumer-focused marketing approach (it had an entire team of R&D, finance and marketing execs outfitted with an electronic system that, for a week, at all times of day, signaled them to react to the unpleasant gastrointestinal events of ulcerative colitis patients). And if—as this blogger believes--spec pharmas are going to be P&G’s biggest dealmaking competition, then P&G really will have an interesting advantage.

The pitch worked for Aryx Therapeutics, one of two companies with whom P&G has signed deals since its reorganization (the other is Nastech, for nasal-delivered parathyroid hormone). The Aryx drug, for GERD and gastroparesis, hit all the P&G criteria: a GI product (for GERD and gastroparesis) and risk-reduced (works like Propulsid but, apparently, avoids the drug-drug interactions which killed it). “We had three virtually identical term sheets,” says Aryx VP and COO John Varian but chose P&G because of their “focus on the consumer.”

Still, P&G is hardly burning up the dealmaking track. They’ve done two deals since their restructuring—the last in July 2006. Davis is confident that in ’07 his group will be able to get to terms sheets on 2-3 programs. There are plenty of biotechs who'll appreciate the P&G approach. But we wonder whether the Consumer King will tolerate the risk of signing them.

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